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Completed

NCT Number: NCT07825168

Telerehabilitation in Patients With Peripheral Arterial Disease

This prospective longitudinal study evaluated the feasibility, adherence, and clinical and functional effects of a 6-month home-based telerehabilitation program in patients with peripheral arterial disease of the lower limbs. The program consisted of walking-based physical activity monitored using a smartwatch and weekly telephone counselling. Patients were encouraged to progressively increase their daily physical activity, with assessments performed at baseline, 3 months, and 6 months.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spitalul Clinic de Recuperare Iași

Iași, Iaşi, 700686, Romania

About this study

This prospective, single-arm study evaluated the feasibility and implementation of a 6-month home-based telerehabilitation program in patients with peripheral arterial disease (PAD) of the lower limbs. The intervention consisted of an individually prescribed walking-based physical activity program performed at home, supported by wearable activity monitoring and weekly telephone counselling. Participants used a Xiaomi Smart Band 8 to monitor daily step counts and were encouraged to progressively increase their physical activity according to individualized weekly targets. During the weekly telephone contacts, the investigator reviewed the participant's activity during the preceding 7 days, assessed adherence and provided individualized encouragement and guidance regarding continuation and progression of the walking program.

Clinical, functional, laboratory, and health-related quality-of-life assessments were performed at baseline, 3 months, and 6 months. Functional evaluation included the 6-minute walk test, ankle-brachial index, and cardiopulmonary exercise testing. Laboratory assessments included selected cardiometabolic and inflammatory parameters. Disease-specific health-related quality of life was assessed using validated PAD-specific questionnaires.

The study was designed to evaluate the feasibility and adherence to a digitally supported home-based rehabilitation model and to explore longitudinal changes in physical activity, functional capacity, quality of life, and selected clinical and laboratory parameters during the 6-month intervention period. As the study used a single-arm design without a control group, longitudinal changes were considered exploratory and cannot be interpreted as causal effects of the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥18 years;
  • diagnosis of PAD, defined by an ankle-brachial index (ABI) ≤0.90, arterial stenosis >70% documented by angiography, or previous lower-extremity revascularization;
  • ability to safely perform walking exercise at home;
  • ability to use the activity-monitoring device and read the number of daily steps displayed on the device;
  • access to and ability to use a mobile phone for telephone counseling;
  • ability to complete the activity journal;
  • provision of written informed consent.

Exclusion criteria

  • chronic limb-threatening ischemia (CLTI);
  • locomotor disability preventing participation in the walking exercise program;
  • significant visual or hearing impairment interfering with participation in the in-tervention;
  • moderate-to-severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score <17 [17];
  • requirement for long-term oxygen therapy;
  • incomplete medical records;
  • inability to provide reliable information required for study assessments.

Treatment and study plan

Home-Based Telerehabilitation

Behavioral

A 6-month home-based walking program supported by smartwatch-based monitoring of daily step counts and weekly telephone counselling. During weekly telephone contacts, the investigator reviewed the participant's activity during the preceding 7 days, assessed adherence, and provided individualized guidance and encouragement to continue and progressively increase walking activity.

Primary outcomes

  1. Achievement of the prescribed average daily step target

    Time frame: Throughout the 6-month intervention period

    Percentage of weeks in which the participant achieved the average daily step target established for the following week.

  2. Increase in average daily step count

    Time frame: Throughout the 6-month intervention period

    Percentage of weeks in which average daily steps increased compared with the previous week.

  3. Weeks exceeding an average of 5,000 steps per day

    Time frame: Throughout the 6-month intervention period

    Percentage of weeks in which the participant exceeded an average of 5,000 steps per day.

  4. Weeks exceeding an average of 10,000 steps per day

    Time frame: Throughout the 6-month intervention period

    Percentage of weeks in which the participant exceeded an average of 10,000 steps per day.

  5. Median average daily step count during each 12-week period

    Time frame: Throughout the 6-month intervention period

    Median average daily step count during each 12-week period of the intervention.

Secondary outcomes

  1. Distance to onset of intermittent claudication

    Time frame: Baseline, 3 months, and 6 months

    Distance (meters) walked until the onset of intermittent claudication symptoms during the 6-minute walk test.

  2. 6-Minute Walk Test distance

    Time frame: Baseline, 3 months, and 6 months

    Total distance (meters) walked during the 6-minute walk test.

  3. Percentage of predicted 6-Minute Walk Test distance

    Time frame: Baseline, 3 months, and 6 months

    Percentage of predicted 6-minute walk distance achieved during the test.

  4. Heart rate during cardiopulmonary exercise testing

    Time frame: Baseline, 3 months, and 6 months

    Heart rate (beats/minute) measured during cardiopulmonary exercise testing.

  5. Maximum exercise workload

    Time frame: Baseline, 3 months, and 6 months

    Maximum exercise workload (watts)achieved during cardiopulmonary exercise testing.

  6. Oxygen consumption (VO2)

    Time frame: Baseline, 3 months, and 6 months

    Oxygen consumption (mL/kg/min) measured during cardiopulmonary exercise testing.

  7. VE/VCO2 ratio

    Time frame: Baseline, 3 months, and 6 months

    Minute ventilation to carbon dioxide production ratio during cardiopulmonary exercise testing.

  8. PADQOL score

    Time frame: Baseline, 3 months, and 6 months

    Health-related quality of life assessed using the PADQOL questionnaire (points).

  9. QOLPAD score

    Time frame: Baseline, 3 months, and 6 months

    Health-related quality of life assessed using the QOLPAD questionnaire (points).

  10. VascuQoL-6 score

    Time frame: Baseline, 3 months, and 6 months

    Health-related quality of life assessed using the VascuQoL-6 questionnaire (points).

  11. Systolic blood pressure

    Time frame: Baseline, 3 months, and 6 months

    Systolic blood pressure (mmHg) measured during clinical assessment.

  12. Diastolic blood pressure

    Time frame: Baseline, 3 months, and 6 months

    Diastolic blood pressure (mmHg)measured during clinical assessment.

  13. Ankle-brachial index

    Time frame: Baseline, 3 months, and 6 months

    Ankle-brachial index calculated as the ratio of ankle to brachial systolic blood pressure.

  14. Body mass index

    Time frame: Baseline, 3 months, and 6 months

    Body mass index (kg/m²)calculated from body weight and height.

  15. Fasting glucose

    Time frame: Baseline, 3 months, and 6 months

    Fasting blood glucose concentration (mg/dL).

  16. Glycated hemoglobin (HbA1c)

    Time frame: Baseline, 3 months, and 6 months

    Glycated hemoglobin(%) measured during laboratory assessment.

  17. Total cholesterol

    Time frame: Baseline, 3 months, and 6 months

    Serum total cholesterol concentration (mg/dL).

  18. HDL cholesterol

    Time frame: Baseline, 3 months, and 6 months

    Serum high-density lipoprotein cholesterol concentration (mg/dL).

  19. LDL cholesterol

    Time frame: Baseline, 3 months, and 6 months

    Serum low-density lipoprotein cholesterol concentration (mg/dL).

  20. Triglycerides

    Time frame: Baseline, 3 months, and 6 months

    Serum triglyceride concentration (mg/dL).

Sponsors and collaborators

Lead sponsor

Grigore T. Popa University of Medicine and Pharmacy

Other

Registry information

Official study title

Results of a Study Based on a Telerehabilitation Program in Patients With Peripheral Arterial Disease of the Lower Limbs

Acronym: PAD_TR

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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